Healthcare News by GLG Council Members

Ken PowellPresidentGenesis Business Development, LLC

Gen-Probe Files Patent Lawsuit Against BD

October 22, 2009

Analysis of:Gen-Probe Files Patent Infringement Suit Against Becton Dickinson | www.genomeweb.com

Gen-Probe filed a patent infringement lawsuit against BD this week alleging that sales of BD's Viper with XTR technology and ProbeTec molecular diagnostic systems infringe several Gen-Probe patents.  The two companies compete against one another in the large molecular diagnostics test segment for sexually transmitted diseases that include chlamydia and gonorrhea. 

denosumab approval delayed

October 21, 2009

Analysis by: GLG Expert Contributor

Analysis of:denosumab approval delayed | www.pharmatimes.com

Amgen's osteoporosis drug denosumab is delayed fda approval.

We need to learn more about ProSavin Phase I/II Trial in Parkinson’s disease

October 20, 2009

Analysis by: GLG Expert Contributor

Analysis of:Oxford BioMedica Announces Update on ProSavin® Phase I/II Trial in Parkinsons Disease And Publication of Preclinical Results | www.pipelinereview.com

This is very interesting news. However, in my judgment it is too early to make a final conclusion concerning this clinical trial. Because it should be taken into account that the growing body of evidence clearly indicates that oxidative stress induced mitochondrial failure appeared to be one of the main reasons for the selective neuronal damages that occurs in Parkinson’s disease. 

Ken PowellPresidentGenesis Business Development, LLC

Quest Diagnostics Receives Second FDA H1N1 EUA

October 20, 2009

Analysis of:FDA Grants Second Authorization for Focus Diagnostics' H1N1 Flu Test | www.genomeweb.com

Quest Diagnostics subsidiary Focus Diagnostics has received a second FDA Emergency Use Authorization for its H1N1 molecular diagnostic test.  Marketed under the name Simplexa Influenza A H1N1, it can now be used on 3M's Integrated Cycler by CLIA high-complexity laboratories for the duration of the emergency period.

GSK's cervical cancer vaccine Cervarix gains approval in Japan

October 19, 2009

Analysis by: GLG Expert Contributor

Analysis of:GSK's cervical cancer vaccine Cervarix gains approval in Japan | www.pharmabiz.com

GlaxoSmithKline (GSK) gained approval for Cervarix in Japan, which becomes the first cervical cancer vaccine to be approved by the Japanese Ministry of Health, Labour and Welfare (MHLW). This approval marks a significant milestone for GSK, as Cervarix will be the first to be launched by the company's Japanese business.

Pfizer fine for inappropriate bextra marketing

October 19, 2009

Analysis by: GLG Expert Contributor

Analysis of:Pfizer Subsidiary Hit With Record Fine For Misbranding Bextra | online.wsj.com

Fines for inappropriate marketing are part of the cost of doing business for Big Pharma. However they seem to be changing their marketing to physicians due to government scrutiny.

Kelly ClosePresidentClose Concerns

Major Turnaround- NEJM VADT Correction Shows MVC Benefits of Intensive Control

October 19, 2009

Analysis of:Veterans Affairs Diabetes Trials- Corrections | content.nejm.org

The authors of the original Veterans Affairs Diabetes Trial (VADT) published a correction in the September 3, 2009 issue of the NEJM indicating that the rate of progression to microalbuminuria was misreported in the original trial publication. Updated numbers show a meaningful and statistically significant reduction of progression to albuminuria for the intensive treatment group.

Animal vaccine maker Merial expands Nanchang China plant

October 18, 2009

Analysis by: GLG Expert Contributor

Analysis of:Sanofi vet group plots $70M China expansion | www.fiercepharma.com

Ground breaks for expansion of avian vaccine maker Merial (Sanofi-Aventis). US dollars spent to feed China. Expanding poultry vaccine for domestic Chinese market.

Newer info on Enbrel, not really that surprising.

October 18, 2009

Analysis by: GLG Expert Contributor

Analysis of:New data from PRESTA trial demonstrate the benefit of Enbrel in patients with psoriasis & psoriatic arthritis | www.pharmabiz.com

More good results for enbrel in psoriasis and psoriatic arthritis.

Another tnf blocking agent?

October 18, 2009

Analysis by: GLG Expert Contributor

Analysis of:Cimzia®, the only PEGylated anti-TNF, approved in Europe and available in a syringe designed in partnership with OXO Good Grips® | www.pipelinereview.com

Cimzia is another tnf blocking med, approved for RA and Chron's.

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